Otc - Active Ingredient
Povidone-lodine 1%
Nasal Solution Liquid
FDA Label NDC 84008-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bullet Point Llc for the product Nasal Solution (NDC 84008-101). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, inactive ingredient, otc - purpose, indications & usage, otc - do not use, otc - ask doctor, otc - keep out of reach of children, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
Purifed water,xylitol, vitamin D3,polysorbate, gellangum, carrageenan, sodiumhydroxide, aloe vera.
Otc - Purpose
*Gently washes and soothesthe delicate nasal passage.
*Helps clean away viruses,pollen, dust, and otherairborne contaminantsand germs.
Thins and loosens mucussecretion.
*Aids in improving airflow.
*Powerful sinus protection.
*Fast congestion relief.
Indications & Usage
Uses:
*Congested nose andsinuses.
*lrritated and itchy nose.
*Nasal exposure to bacteria,dust and other airbornecontaminants.
Otc - Do Not Use
Avoid use if you're allergicto iodine or inactive ingredient(s).Avoid contactin the eyes. Avoid use onchildren under 3 years old.
Otc - Ask Doctor
Stop use and consult adoctor if symptoms persistor worsen, swelling,infection, rash or feveroccurs.lf pregnant orbreast- feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach ofchildren. lf swallowed, getmedical help or contact the poison control center rightaway.
Otc - Pregnancy Or Breast Feeding
lf pregnant orbreast- feeding, ask a health professional before use.
Warnings
Use of container bymore than one person canspread infection.
Dosage & Administration
Directions:
Adults and children over 6years of age: 1 spray in eachnostril not more than 3times in any 24-hour period,Children under é years ofage: Consult a doctor.
For the frst time -Removesafety seal and original capfrom bottle. insert dip tubeinto bottle, and screw on.
Gently blow your nose toclear the nasal passageway.Shake the product well,remove the cap, and thenspray it quickly and frmlyup your nostril.
Do not tilt your headbackward during sprayingAfter use, wipe the spraynozzle clean and securelyreattach the cap.
Otc - Questions
You can email us at [email protected] for more help!
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